MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 12MM; SCREW, FIXATION, BONE

Catalog Number 412.812

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional pro-code: hrs.Review of the device history record has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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) follows: during inspection, the warehouse team detected one packet of 412.812 (lot 32p7189, manufactured 10-12-2019) containing two pieces of screws within the original, sealed packaging instead of one piece as per product label.This complaint involves one (1) device.This report is 1 of 1 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.H3, h4, h6: part number: 412.812, lot number: 32p7189, manufacturing site: grenchen, release to warehouse date: 11 december 2019.A manufacturing record evaluation was performed for the finished device with lot number 32p7189, and no non-conformances were identified.Picture review: narrative (two screws in the package) could be verified from provided pictures.A package containing two locking screws was returned for investigation.Package was forwarded to the manufacturing site and was checked for conformance to the specifications.Summary of manuf evaluation: the received condition of the complaint agrees with the complaint description since the sealed and original depuy synthes package contained two screws, instead of a single one, as claimed by the customer.In addition, from the manufacturing point of view this complaint is rated as confirmed and valid since a manufacturing deficiency has been identified in the step 60 ¿packaging¿, due to the fact that two (2) titanium locking screws with stardrive were packaged and sealed inside a single depuy synthes bag.Additional investigation will be conducted.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: 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 12MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9857243
• MDR Text Key: 191675351
• Report Number: 8030965-2020-02123
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819121133
• UDI-Public: (01)07611819121133
• Combination Product (y/n): N
• PMA/PMN Number: K103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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 Catalogue Number: 412.812
• Device Lot Number: 32P7189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 03/30/2020
• Supplement Dates FDA Received: 04/22/2020
• Patient Sequence Number: 1