MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LCP 2 STR 8HO L59 TI; PLATE,FIXATION,BONE

Catalog Number 447.348

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record review was requested.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.(b)(4).See [mw5077445 05jun2018.Pdf].

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: this report is against mw5077445.The only information contained in this report is correction or additional information.This complaint is submitted following a request to create an additional report to complaint (b)(4) - since there are 2 patients involved.We received a letter from the healthcare professional in which the event is described.Please see the attached word file with the details regarding the event and related products.The procedure was done using depuy synthes plate and locking screws (401.880-401.882-401.362-447.348) on (b)(6) 2017 - open reduction internal fixation surgery of rt.Ulnar bone.The procedure was done using depuy synthes plate and locking screws.Patient had allergic reactions.Due to refractoriness to treatment and deteriorating clinical state, and possible asia- plate and screws were taken out on (b)(6) 2018.This is report 1 of 4 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.447.348; lot: l567593; manufacturing site: mezzovico; release to warehouse date: september 14, 2017; the device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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.

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.Device history lot part: 447.348, lot: l567593, manufacturing site: mezzovico, release to warehouse date: 14.Sep.2017.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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: LCP 2 STR 8HO L59 TI
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7619674
• MDR Text Key: 111711313
• Report Number: 8030965-2018-54421
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K063049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 447.348
• Device Lot Number: L567593
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 08/13/2018; 02/17/2020
• Supplement Dates FDA Received: 08/15/2018; 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR