MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 09X10X10MM; STAPLE, FIXATION, BONE

Model Number	SE-0910
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, the speed compression implant was incompatible with the insertion handle.There was no patient consequence.There is no further information available.This report is for one (1) speed compression implant kit 09x10x10mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Reporter is a j&j employee.The speed compression implant kit 09x10x10mm (part# se-0910, lot# bse180741) was returned and received at us cq.Upon visual inspection, device was received in its original sealed package and the implant was deployed from the inserter and was freely moving inside the package, confirming the complaint condition.No other issues were identified with the returned device.Functional testing of the received test was not performed at cq as the device was received in its original sealed packaging and it was confirmed by visual inspection that the implant had been deployed from the inserter.Can the complaint be replicated with the returned device(s)? unable to perform.A dimensional inspection was not performed as the complaint condition was confirmed via visual inspection and the failure mode was known to be related to historical packaging configurations.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Complaint confirmed? yes.The complaint condition was confirmed for the speed compression implant kit 09x10x10mm (part# se-0910, lot# bse180741).There is no indication that a manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that the most probable root cause for this type of complaint is the historical packaging design, with transit/handling being a contributing factor.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not required.However, change order 4551 was released on august 23, 2018 with an update to the packaging traveler for speed implants, indicating to package the loaded inserter with the release button facing down, instead of facing up, to avoid the tray pushing on it as seen on this complaint.The potential impact of the design to the complaint condition is addressed under capa.No further corrective action is deemed necessary at this time.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part #: se-0910 lot #: bse180741 manufacturing site: biomedical enterprises, inc.Release to warehouse date: 31jul2018 expiration date: 31jul2023 no ncrs were generated during production.Device history review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition 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
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Reporter is a j&j employee.The speed compression implant kit 09x10x10mm (part# se-0910, lot# bse180741) was returned and received at us cq.Upon visual inspection, device was received in its original sealed package and the implant was deployed from the inserter and was freely moving inside the package, confirming the complaint condition.No other issues were identified with the returned device.Functional testing of the received test was not performed at cq as the device was received in its original sealed packaging and it was confirmed by visual inspection that the implant had been deployed from the inserter.Can the complaint be replicated with the returned device(s)? unable to perform.A dimensional inspection was not performed as the complaint condition was confirmed via visual inspection and the failure mode was known to be related to historical packaging configurations.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Complaint confirmed? yes.The complaint condition was confirmed for the speed compression implant kit 09x10x10mm (part# se-0910, lot# bse180741).There is no indication that a manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that the most probable root cause for this type of complaint is the historical packaging design, with transit/handling being a contributing factor.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not required.However, change order 4551 was released on august 23, 2018 with an update to the packaging traveler for speed implants, indicating to package the loaded inserter with the release button facing down, instead of facing up, to avoid the tray pushing on it as seen on this complaint.The potential impact of the design to the complaint condition is addressed under capa.No further corrective action is deemed necessary at this time.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part #: se-0910 lot #: bse180741 manufacturing site: biomedical enterprises, inc.Release to warehouse date: 31jul2018 expiration date: 31jul2023 no ncrs were generated during production.Device history review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition 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 an unknown date, the speed compression implant was incompatible with the insertion handle.There was no patient consequence.There is no further information available.This report is for one (1) speed compression implant kit 09x10x10mm.This is report 1 of 1 for (b)(4).

• Brand Name: SPEED COMPRESSION IMPLANT KIT 09X10X10MM
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13156149
• Report Number: 2939274-2022-00007
• Device Sequence Number: 4146790
• Product Code: JDR
• UDI-Device Identifier: 00810633020111
• UDI-Public: (01)00810633020111
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: SE-0910
• Device Catalogue Number: SE-0910
• Device Lot Number: BSE180741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - INSERTION INSTRUMENTS: TRAUMA
• Patient Sex: Unknown