MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS; MISC ORTHO SURGICAL INSTR

Model Number	03.025.040
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient ids: (b)(6).Device is not expected to be returned for manufacturer review/investigation.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2019, during trochanteric femoral nail procedure, one (1) protection sleeve would not slide into one (1) aiming arm.Protection sleeve would not slide all the way through the jig and is now stuck.The procedure ended up free handing for a perfect circle to complete the case.Surgeon lost a perfect reduction due to x-ray team having to re-position the patient to free hand drill under x-rays.There was a surgical delay of 1 hour and 30 minutes.The procedure was successfully completed.Patient outcome was successful/no patient consequence.This report is for one (1) protection sleeve.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The instrument(s) was not returned and instead will be do based on the supplied image(s) from the attachments (1 image(s) from the attachment(s) located in notes & attachments section of the product complaint).The image(s) (1 total) was reviewed and the complaint condition for unable to assemble could not be confirmed as the image(s) showed the instrument together however it could not be determined if there stuck together.As the instrument(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the supplied image(s).No definitive root cause was able to be determined as the complaint could not be confirmed.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A review of the device history record.Part: 03.025.040 lot: 9934008 manufacturing site: hägendorf, release to warehouse date: 30.June 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.,part: 03.025.040 lot: 9934008 manufacturing site: hägendorf release to warehouse date: 30.June 2016 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary investigation background: modified event description: it was reported that on (b)(6) 2019, during trochanteric femoral nail procedure, one (1) protection sleeve would not slide into one (1) aiming arm.Protection sleeve would not slide all the way through the jig and is now stuck.The procedure ended up freehanding for a perfect circle to complete the case.There was a surgical delay of 1 hour and 30 minutes.The procedure was successfully completed.Patient outcome was successful/no patient consequence.The instrument(s) was not returned and instead will be do based on the supplied image(s) from the attachments (1 image(s) from the attachment(s) located in notes & attachments section of the product complaint).The image(s) (1 total) was reviewed and the complaint condition for unable to assemble could not be confirmed as the image(s) showed the instrument together however it could not be determined if there stuck together.As the instrument(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the supplied image(s).No definitive root cause was able to be determined as the complaint could not be confirmed.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed; investigation site: hägendorf shipped back device ¿11.0mm/8.0mm protection sleeve 188mm for asls¿ with lot number 9934008 is in used conditions.As stated in the complaint description it is stuck into component 03.037.013 apposite channel.Scratches are visible on the device and on both the extremities are present damage marks.Most likely the device did not fit in the channel and it was used a hammer to force the passage through the channel.The device was separated by the other one (component 03.037.013).The following documents were reviewed: ¿ device history record (dhr) 15180357; ¿ inspection sheet ¿pa intern multiple visuelle endprüfung¿ ¿ device history record (dhr) 15209962; ¿ inspection sheet all the documents mentioned above have been analyzed.Human error is most likely to address as root cause, relevant actions have been taken to address the issue.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8641631
• Report Number: 2939274-2019-58288
• Device Sequence Number: 14119131
• Product Code: LXH
• UDI-Device Identifier: 10886982069900
• UDI-Public: (01)10886982069900
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.025.040
• Device Catalogue Number: 03.025.040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 06/10/2019; 07/31/2019; 08/23/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/19/2019; 08/08/2019; 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR