MAUDE Adverse Event Report: SYNTHES GMBH PROTECT SLEEVE 12/8 L188; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.010.063
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Mfr site: (b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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
Device report from synthes reports an event in portugal as follows: it was reported on an unknown date that - 03.010.041 b 14.0/3.2 mm punzón, damaged canulated.Replace.03.010.063 hystic protection plane 12.0/8.0, longitud 188 mm, and a - 03.010.065 bit guide 8.0/4.2, for part no.03.010.063, very difficult to remove from each other, check.There was no surgical delay.There was alteration of the technique by another surgical option existing in the surgical instrument, with no impact on the surgery.There was no patient consequences.This report is for one (1) protect sleeve 12/8 l188.This is report 1 of 3 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: subsequent follow-up with the customer, additional information was received regarding the event.Therefore, the event description has been updated accordingly.D4: the lot number was reported as unknown on the initial report; and has been updated accordingly.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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
Device report from synthese reports an event in portugal as follows: it was reported on an unknown date that - 03.010.041 b 14.0/3.2 mm punzón, damaged canulated.Replace.03.010.063 hystic protection plane 12.0/8.0, longitud 188 mm, and a - 03.010.065 bit guide 8.0/4.2, for part no.03.010.063, very difficult to remove from each other, check there was no surgical delay.There was alteration of the technique by another surgical option existing in the surgical instrument, with no impact on the surgery.There was no patient consequences.The procedure was completed successfully.This report is for one (1) protect sleeve 12/8 l188 this is report 1 of 3 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the protect sleeve 12/8 l188.A dimensional inspection was performed for the protect sleeve 12/8 l188 and met specifications.A functional test could not be performed as the mating device was not returned.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the protect sleeve 12/8 l188 was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed: yes, conforms.Dimensional inspection: conforming.Device history: part: : 03.010.063.Lot no : 1924922.Release to warehouse date: 24 july 2008.Manufacturing site: werk hagendorf.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: PROTECT SLEEVE 12/8 L188
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15190819
• Report Number: 8030965-2022-05649
• Device Sequence Number: 5914840
• Product Code: LXH
• UDI-Device Identifier: 07611819760905
• UDI-Public: (01)07611819760905
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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 Catalogue Number: 03.010.063
• Device Lot Number: 1924922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 08/11/2022; 09/23/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 08/31/2022; 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown