MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.9MM LOCKING BOLT 36MM; PIN, FIXATION, THREADED

Catalog Number 259.360S

Device Problem No Apparent Adverse Event (3189)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) reports an event as follows: it was reported that on an unknown date, the patient had an allergic reaction.The procedure was performed in the (b)(6) clinic on (b)(6) 2019.The procedure was performed without issue for a walking disorder.The patient then presented with a face rash which the surgeon believes could be an allergic reaction.No further information provided.This report is for one (1) 4.9 mm locking bolt 36 mm.This is report 2 of 3 for pc-(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.D4: specific lot remains unknown.Lots 4l06951, 4l26902, 4l32026, 4l67030, 4l88721, 5l09157 are suspected lots.H3, h6: part:259.360, lot: 4l06951, manufacturing site: grenchen, release to warehouse date: march 27, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Part:259.360, lot: 4l26902, manufacturing site: grenchen, release to warehouse date: april 8, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Part:259.360, lot: 4l32026, manufacturing site: grenchen, release to warehouse date: april 17, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Part:259.360, lot: 4l67030, part/lot combination are unknown at synthes gmbh, no dhr review possible.Part:259.360, lot: 4l88721, manufacturing site: grenchen, release to warehouse date: june 3, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Part:259.360, lot: 5l09157, manufacturing site: grenchen, release to warehouse date: june 21, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 4.9MM LOCKING BOLT 36MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9597092
• MDR Text Key: 175265241
• Report Number: 8030965-2020-00414
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07611819253797
• UDI-Public: (01)07611819253797
• Combination Product (y/n): N
• PMA/PMN Number: K970097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 259.360S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention