MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH POLY SCREW DRIVER RETEN SLEEVE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 2020-00-401

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during an inspection, it was noted that the two parts of the poly screwdriver did not fit together properly.No surgery or patient affected.This report is for one (1) poly screw driver reten sleeve.This is report 1 of 2 for (b)(4).

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.H3, h6: a review of the receiving inspection (ri) for poly screw driver reten sleeve was conducted identifying that lot number pc4958137 was released in a single batch.Batch 1: released on january 07, 2020 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.Visual inspection: the poly screw driver reten sleeve was returned and received at us customer quality (cq).Upon visual inspection, no visual defects were observed on the device.Functional test: the functional test was performed with the returned devices.The poly screwdriver shft x20 (mating part) was not going through the complaint device as the mating part shaft was deformed at the proximal groove distal edge.No defects were observed on the compliant device, thus the complaint condition for the complaint device was not confirmed.Dimensional inspection: the dimensional inspection was not performed as no defects were observed on the device.Document/specification review: based on the date of manufacture, the following drawings, reflecting the current and manufactured revisions, were reviewed 103140293 polyscrewdriver retention sleeve assembly investigation conclusion: the complaint condition was not confirmed for the returned device as no defects were observed on the device.The defect on the mating device caused the alleged complaint condition.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 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: POLY SCREW DRIVER RETEN SLEEVE
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10517967
• MDR Text Key: 219149603
• Report Number: 1526439-2020-01638
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705034532776
• UDI-Public: (01)10705034532776
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2020-00-401
• Device Catalogue Number: 202000401
• Device Lot Number: PC4958137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: POLY SCREW DRIVER SHFT X20