MAUDE Adverse Event Report: DEPUY SPINE INC STANDARD REDUCTION HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286735735
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The instrument(s) was not returned, and the investigation will be completed based on the supplied image(s).The image(s) was reviewed, and the complaint condition is confirmed as the image showed a portion of the handle is broken and the button that belongs in the top section of the handle is missing from it.As the instrument(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was performed and no issues were noted.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (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.A device history record (dhr) review was conducted: a review of the receiving inspection (ri) for standard reduction handle was conducted identifying that lot number so2025901 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 25 jun 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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) 2020, it was noticed that the handle is missing the button and is broken.The handle was not needed and was not used during the case, but the scrub tech found the handle in the broken condition upon opening the kit for the case.Procedure was successfully completed with no surgical delay.There was no patient consequences.This report is for one (1) standard reduction handle.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- of the standard reduction handle (part code: 2867-35-735 & lot no: s02025901) was received at us cq.The visual inspection of the received device showed that a piece of the handle was broken off at the most proximal end.Dowel pin, wave spring, and lock button components were missing on the received lower handle component.Upper handle and upper core components assembly was not returned.There were no other damages observed on the device except normal wear which would not contribute to the alleged complaint condition.The overall complaint was confirmed for the received device as a piece of the handle was broken off and dowel pin, wave spring, and lock button components were missing.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.Device history lot = > a review of the receiving inspection (ri) for standard reduction handle was conducted identifying that lot number so2025901 was released in a single batch.¿ batch1: lot were released on 25 jun 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.,a review of the receiving inspection (ri) for standard reduction handle was conducted identifying that lot number so2025901 was released in a single batch.¿ batch1: lot were released on 25 jun 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.,the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: STANDARD REDUCTION HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10818767
• Report Number: 1526439-2020-02147
• Device Sequence Number: 4086648
• Product Code: LXH
• UDI-Device Identifier: 10705034214672
• UDI-Public: (01)10705034214672
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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 Model Number: 286735735
• Device Catalogue Number: 286735735
• Device Lot Number: SO2025901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1