MAUDE Adverse Event Report: SYNTHES HAGENDORF AWL F/TEN

Catalog Number	359.213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: manufacturing location: (b)(4); manufacturing date: 06.Oct.2005.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes on an event in (b)(6) as follows: it was reported that is was an open fracture reduction in humeral shaft with internal fixation.When the specialist performed the piercing with the punch, the tip broke.No prolongation of the surgery was reported.Patient status is normal.The puncture tip, that was split, was inside the channel of the patient's bone; however, the specialist stated that it does not represent any risk to the patient.The procedure was completed successfully.No other medical intervention was required.This complaint involves 1 part.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: device returned to manufacturer.(b)(6).A product investigation was performed.The investigation shows that the tip of the awl is broken as described in the complaint description.The broken tip part was not returned.There are different nicks and striations signs on the entire device visible.The review of the production histories revealed that this awl was manufactured in october 2005 according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.Because of the damage, the complaint relevant dimensions cannot be checked anymore.Since this instrument is quit old it is considered as normal wear and tear after frequent use.Although the exact cause cannot be determined, this complaint condition is likely a result of wear and tear.No product related issues were found.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.
Additional Manufacturer Narrative
Initial (b)(4) submitted as product malfunction only has been corrected to product malfunction and serious injury.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.
Additional Manufacturer Narrative
(b)(4).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: AWL F/TEN
• Common Device Name: AWL
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6258797
• Report Number: 3003875359-2017-10024
• Device Sequence Number: 16362331
• Product Code: HWJ
• UDI-Device Identifier: 07611819096622
• UDI-Public: (01)07611819096622(10)1399899
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/26/2016

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 359.213
• Device Lot Number: 1399899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/26/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 02/27/2017; 03/09/2017; 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention