MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOHMANN-STYLE ARM 183MM; FORCEPS

Model Number 398.752

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Event year reported as 2019; however exact date of event is unknown.Reporter is synthes sales consultant.A device history record (dhr) review was conducted: part: 398.752, lot: 14-9139, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 21.Jul.2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Correct material with hardness measured within specification is documented in coc from supplier for all components.A product investigation was conducted.Visual inspection: the hohmann-shape arm f/collinear reduction clamp (part # 398.752, lot # 14-9139, mfg # 21-jul-2014) was received at us cq with the shape arm separate from the rest of the device.The shape arm broke off from the rest of the device.The weld did not hold.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was not performed as there is no relevant dimension to the weld not holding.Document/specification review: the relevant drawing(s) was reviewed; correct material with hardness measured within specification is documented in coc from supplier for all components.Conclusion: the complaint condition is confirmed as the clamp (part # 398.752, lot # 14-9139) was received with the shape arm separate from the rest of the device.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.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 on an unknown date in 2019, the hook of the hohmann-style arm for collinear reduction clamp had disengaged and fell apart during surgery.It is unknown if there was surgical delay.Procedure outcome and patient status are unknown.This report is for one (1) hohmann-style arm 183mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: HOHMANN-STYLE ARM 183MM
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8466227
• MDR Text Key: 140506581
• Report Number: 2939274-2019-57180
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982201560
• UDI-Public: (01)10886982201560
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2019

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: 398.752
• Device Catalogue Number: 398.752
• Device Lot Number: 14-9139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1