MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM FLEXIBLE SHAFT; REAMER

Model Number 352.040

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2020, that during an unknown procedure, at the time of the reconstruction technique, the guide wire went outside the femoral head and then the nail was slightly removed.The protection sleeve was placed again with the drill sleeve to carry out the insertion of the guide wire again.It happened that this collided with the nail and did not pass.The surgeon performed a maneuver with a tissue protection sheath so the guide wire could be placed in the femoral head.It was also noted that the flexible shaft tip was deteriorated and did not grip the milling heads well.This complaint involves four (4) devices.This report is for one (1) 5.0mm flexible shaft.This is report 4 of 4 for (b)(4).

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.Visual inspection: the synream flex shaft (p/n: 352.040, lot #: unk) was returned and received at us cq.Upon visual inspection, it was observed that the device is bent.The etch on the device started to fade and there were scratches on the shaft but have no impact on the device functionality.No other issues were observed with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Dhr cannot be performed as the lot number is faded.The complaint was confirmed.The device received was bent.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the 5.0mm flexible shaft (p/n: 352.040, lot #unk).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 unk.Dhr cannot be performed since the lot number is unk.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

Updated event description.This complaint involves eight (8) devices.

• Brand Name: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10201647
• MDR Text Key: 196649656
• Report Number: 8030965-2020-04490
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194114
• UDI-Public: (01)10886982194114
• 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: 06/16/2020

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
• Device Operator: Health Professional
• Device Model Number: 352.040
• Device Catalogue Number: 352.040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRILLSL 8/4.2 F/03.010.063; DRILLSL 8/4.2 F/03.010.063; GUIDEWIRE Ø3.2 L400; GUIDEWIRE Ø3.2 L400; GUIDEWIRE Ø3.2 L400; GUIDEWIRE Ø3.2 L400; GUIDEWIRE Ø3.2 L400; PROTECT SLEEVE 12/8 L188; PROTECT SLEEVE 12/8 L188; UNK - NAILS; DRILLSL 8/4.2 F/03.010.063; GUIDEWIRE Ø3.2 L400; PROTECT SLEEVE 12/8 L188