MAUDE Adverse Event Report: SYNTHES HAGENDORF INS F/DHS/DCS IMPACTOR NO. 338.280 SINGL

Catalog Number 338.260

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Device is an instrument and is not implanted/explanted.Telephone number: (b)(6).We have received the article 338.260 / 9374905 for investigation, here is the statement: upon visual inspection of the complaint device it can be seen that on the proximal end of the device (tip) there are some worn places and some cracks (damage) visible, also some pieces of the tip are missing, this thus confirming the complaint description.A device history record (dhr) review was performed for the affected lot, no abnormalities or deviations were detected, which could lead to the complaint failure.Moreover, a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.There is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we have to reasonably conclude that during operation an application error may have taken place, and/or that wear and tear from often use and/or that mechanical overload situation, as excessive force through hammer blows, led to this damage.We classify this as normal wear and tear and such instruments must be replaced from time to time.To prevent such problems, it is necessary worn or damaged instruments to replace and/or to operate according to the technique guide.We classify this as normal wear and tear and such instruments must be replaced from time to time.Manufacturing location: (b)(4).Manufacturing date: 26.Mar.2015.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.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 (b)(4) reports an event in (b)(6) as follows: it was reported about a procedure: neck of femur fracture - open reduction internal fixation with dhs.During implanting of dhs, and impacting down of dhs plate using dhs impactor 338.280, a small fragment on the tip of the impactor broke off.Impactor still usable, so no delay in surgery.The broken fragment easily retrieved.No adverse event to patient.Concomitant devices reported: dhs plate, part unknown, lot unknown, quantity x 1.This is report 1 of 1 for (b)(4).

• Brand Name: INS F/DHS/DCS IMPACTOR NO. 338.280 SINGL
• Type of Device: IMPACTOR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6751773
• MDR Text Key: 82112802
• Report Number: 3003875359-2017-10364
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 07611819022102
• UDI-Public: (01)07611819022102(10)9374905
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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
• Type of Report: Initial
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.260
• Device Lot Number: 9374905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2017
• Date Device Manufactured: 03/26/2015
• 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